Senior Quality Operations Leader – Biopharma

Ferring Holding SA; Roseville (MN); On-site; USD 121,000 - 173,000; Full time

Benefits offered by this job

Healthcare

401(k)

Paid parental leave

Job summary

Ferring Holding SA in Roseville, Minnesota is seeking a Senior Manager Quality Operations to lead quality systems across Manufacturing Operations, Technical Services, and R&D support for Clinical and Commercial products. You will manage a team to ensure product quality, batch records, COA issuance, and disposition in line with cGMP and 21 CFR regulations.

This role requires 7+ years of management in FDA-regulated manufacturing, with pharma/biopharma experience and solid knowledge of GMP rules.

Qualifications

• Seven or more years of management experience.
• Seven or more years of experience in an FDA regulated manufacturing environment with Quality Assurance experience for medical products.
• At least three of these years in a pharmaceutical and/or biopharmaceutical environment.
• Knowledge of quality regulations and current industry practices.
• In-depth knowledge of 21 CFR 210 & 211 GMP regulations.

Responsibilities

• Lead the Management of Quality Operations Functions: manage batch record issuance, batch record review, analytical testing review, COA creation, and disposition processes per product requirements.
• Manage the Donor and Material Hold program to ensure Quality oversight and control.
• Establish and maintain the lot release schedule to meet customer and site demands.
• Perform technical investigations relating to site deviations, customer complaints and other areas as needed.
• Provide Quality System and Regulatory support related to Investigational Systems, Audits, CMC/IND/BLA reviews.

Skills

Management experience

Regulatory knowledge

FDA GMP knowledge

Pharma/biopharma experience

Quality Assurance experience

Knowledge of quality regulations

Education

Bachelor’s degree in a scientific field

Advanced degree preferred

Job description

Ferring Holding SA in Roseville, Minnesota is seeking a Senior Manager Quality Operations to lead quality systems across Manufacturing Operations, Technical Services, and R&D support for Clinical and Commercial products. You will manage a team to ensure product quality, batch records, COA issuance, and disposition in line with cGMP and 21 CFR regulations.

This role requires 7+ years of management in FDA-regulated manufacturing, with pharma/biopharma experience and solid knowledge of GMP rules.